1 табетка содержит: Активное вещество: вальпроата кальция дигидрат 333 мг, что соответствует содержанию вальпроата кальция 300 мг, в пересчете на вальпроевую кислоту 265 мг.; Вспомогательные вещества: крахмал картофельный, желатин, кремния диоксид, тальк, магния стеарат.
Фармакологические свойства
Противоэпилептический препарат. Оказывает противосудорожное, центральное миорелаксирующее и седативное действие.; Механизм действия связан с повышением содержания тормозного нейромедиатора гамма-аминобутировой кислоты (GABA) в ЦНС вследствие ингибирования фермента GABA-трансферазы, а также уменьшения обратного захвата GABA в тканях головного мозга. При этом уменьшается возбудимость и судорожная готовность моторных зон головного мозга.; По другой гипотезе препарат действует на участки постсинаптических рецепторов, имитируя или усиливая тормозящий эффект GABA. Возможное прямое влияние на активность мембран связано с изменениями в проводимости калия.; Улучшает психическое состояние и настроение больных, обладает антиаритмической активностью.; Высоко эффективен при абсансах и височных псевдоабсансах, мало - при психомоторных припадках.
Показания к применению
Эпилепсия различного генеза: генерализованные и парциальные припадки
Эпилептические припадки на фоне органических заболеваний мозга
Изменения характера и поведения (обусловленные эпилепсией)
Маниакально-депрессивный психоз с биполярным течением, не поддающийся лечению препаратами лития или другими лекарственными средствами
Специфические синдромы (Веста, Леннокса-Гасто)
Противопоказания
Печеночная недостаточность
Острый и хронический гепатит
Нарушения функции поджелудочной железы
Порфирия
Геморрагический диатез
Тромбоцитопения
Детский возраст до 3 лет
Заболевания печени в анамнезе
Повышенная чувствительность к препарату
Применение при беременности и в период грудного вскармливания
При беременности применение Конвульсофина возможно только по строгим показаниям, после тщательной оценки ожидаемой пользы терапии для матери и возможного риска для плода.; При применении Конвульсофина в ранний период беременности повышается риск незаращения нервной трубки у эмбриона (миеломенингоцеле). Наряду с этим могут отмечаться другие аномалии развития плода. Риск образования аномалий развития плода увеличивается при комбинированном применении Конвульсофина с другими противоэпилептическими средствами.; В случае невозможности отказа от проведения терапии Конвульсофином в I триместре препарат назначают в самых низких дозах, а между 20 и 40 днем беременности суточную дозу распределяют на несколько небольших разовых доз в течение дня. Необходимо регулярно контролировать концентрацию вальпроевой кислоты в плазме крови. С целью ранней диагностики аномалий развития плода рекомендуется проводить УЗ-исследования и альфа1 -фетопротеиновый тест.; Вальпроевая кислота выделяется с материнским молоком в незначительных количествах, не представляющих опасности для ребенка, поэтому, как правило, прекращения грудного вскармливания в период терапии Конвульсофином не требуется.
Способ применения и дозы
Внутрь, во время или после еды, не разжевывая и запивая небольшим количеством жидкости.; Во избежание побочных эффектов лечение начинают низкими дозами препарата, затем их постепенно повышают до оптимальных для больного суточных поддерживающих доз. При монотерапии начальная доза Конвульсофина в общем составляет 5–10 мг/кг. Через каждые 4–7 дней эту дозу увеличивают примерно на 5 мг. Средняя суточная доза для взрослых и больных пожилого и старческого возраста составляет 20 мг/кг, для подростков — 25 мг/кг и для детей — 30 мг/кг. В некоторых случаях терапевтическое действие препарата полностью проявляется только через 4–6 нед лечения. Поэтому необходимо следить за тем, чтобы увеличение суточной дозы произошло постепенно. Если Конвульсофин назначают вместе с другими противоэпилептическими средствами или для замещения предшествующего препарата, то дозу раннее принимаемого препарата, в особенности фенобарбитала, немедленно понижают. Полный переход на лечение Конвульсофином производят медленно, постепенно понижая дозу ранее принимаемого препарата.; Обычно руководствуются следующей ориентировочной схемой применения препарата: - детям в возрасте 3–6 лет назначают по 300–600 мг (1–2 табл.) в сутки; ;- детям школьного возраста (6–14 лет) назначают по 450–1500 мг (1,5–5 табл.) в сутки; ;- подросткам старше 14 лет и взрослым назначают по 1200–2100 мг (4–7 табл.) в сутки.; У больных с почечной недостаточностью следует учитывать повышение концентрации свободной вальпроевой кислоты в сыворотке крови и в соответствии с этим снижать суточную дозу Конвульсофина.; По указанию врача суточную дозу препарата распределяют на 2–4 приема в день.; Дозы и длительность применения Конвульсофина устанавливает врач индивидуально для каждого больного.
Побочное действие
Со стороны ЦНС: тремор; редко - изменения поведения, настроения или психического состояния (депрессия, чувство усталости, галлюцинации, агрессивность, гиперактивное состояние, психозы, необычное возбуждение, двигательное беспокойство или раздражительность), атаксия, головокружение, сонливость, головная боль, энцефалопатия, дизартрия, энурез, ступор, нарушение сознания, кома.; Со стороны органов чувств: диплопия, нистагм, мелькание "мушек" перед глазами, нарушение слуха.; Со стороны пищеварительной системы: тошнота, рвота, гастралгия, анорексия или повышение аппетита, диарея, гепатит, незначительное повышение активности печеночных трансаминаз, ЛДГ, гипербилирубинемия; редко - запоры, панкреатит (вплоть до тяжелых поражений с летальным исходом в первые 6 мес лечения, чаще на 2-12-й неделе).; Со стороны системы кроветворения: анемия, лейкопения.; Со стороны свертывающей системы крови: тромбоцитопения, снижение содержания фибриногена, удлинение времени кровотечения, петехиальные кровоизлияния, кровоподтеки, гематомы, повышенная кровоточивость.; Аллергические реакции: кожная сыпь, крапивница, ангионевротический отек, синдром Стивенса-Джонсона.; Дерматологические реакции: фотосенсибилизация, алопеция.; Со стороны мочевыделительной системы: гиперкреатининемия, гипераммониемия.; Со стороны эндокринной системы: дисменорея, вторичная аменорея, увеличение молочных желез, галакторея.; Прочие: увеличение или уменьшение массы тела, периферические отеки, гиперглицинемия.
Передозировка
Симптомы: тошнота, рвота, головокружение, диарея, нарушение функции дыхания, мышечная гипотония, гипорефлексия, миоз, кома (на ЭЭГ увеличение медленных волн и фоновой активности).; Лечение: промывание желудка (не позже 10-12 ч), прием активированного угля, форсированный диурез, поддержание жизненно важных функций, гемодиализ.
Особые указания
С особой осторожностью и под тщательным медицинским наблюдением следует назначать препарат при аплазии костного мозга, патологических изменениях крови, органических заболеваниях головного мозга, гипопротеинемии, почечной недостаточности.; Переход от лечения другим противосудорожным препаратом к терапии Конвульсофином производят медленно, достигая клинически эффективной дозы в течение 2 недель и постепенно понижая дозу предыдущего препарата вплоть до его отмены. У пациентов, не получавших предшествующего лечения противоэпилептическими препаратами, клинически эффективная доза должна быть достигнута через 1 неделю.; Побочное действие чаще возникает при проведении комбинированной терапии, чем при монотерапии Конвульсофином.; Перед хирургическими манипуляциями больным, принимающим Конвульсофин, следует определять количество тромбоцитов, время кровотечения, показатели коагулограммы.; При развитии на фоне приема Конвульсофина симптомокомплекса "острый живот" до начала оперативного вмешательства рекомендуется определить уровень амилазы в крови для исключения острого панкреатита.; При развитии спонтанных гематом и кровотечений и возникновении таких симптомов, как слабость, летаргическое состояние, отечность, рвота и желтуха, следует немедленно прекратить применение препарата.; Следует учитывать, что на фоне приема Конвульсофина возможны ложноположительные реакции на наличие кетоновых тел в моче, искажение показателей функции щитовидной железы.; В период лечения Конвульсофином не допускается прием этанолсодержащих напитков.; Контроль лабораторных показателей; На фоне терапии Конвульсофином необходимо периодически контролировать активность печеночных трансаминаз, уровень билирубина, картину периферической крови, уровень фибриногена в плазме крови, тромбопластиновое время, уровень альфа-амилазы в моче (каждые 3 месяца).; Использование в педиатрии; У детей (особенно до 2 лет) повышен риск развития выраженных нарушений функции печени на фоне приема Конвульсофина.; Влияние на способность к вождению автотранспорта и управлению механизмами; Препарат может ослаблять скорость психомоторных реакций и способность к концентрации внимания, поэтому пациентам, принимающим Конвульсофин, следует воздерживаться от потенциально опасных видов деятельности.
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табетка содержит: Активное вещество: вальпроата кальция дигидрат 333 мг, что соответствует содержанию вальпроата кальция 300 мг, в пересчете на вальпроевую кислоту 265 мг.; Вспомогательные вещества: крахмал картофельный, желатин, кремния диоксид, тальк, магния стеарат."}}]},{"id":2,"name":"Фармакологические свойства","slug":"pharmacologic_effects","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"Противоэпилептический препарат. Оказывает противосудорожное, центральное миорелаксирующее и седативное действие.; Механизм действия связан с повышением содержания тормозного нейромедиатора гамма-аминобутировой кислоты (GABA) в ЦНС вследствие ингибирования фермента GABA-трансферазы, а также уменьшения обратного захвата GABA в тканях головного мозга. При этом уменьшается возбудимость и судорожная готовность моторных зон головного мозга.; По другой гипотезе препарат действует на участки постсинаптических рецепторов, имитируя или усиливая тормозящий эффект GABA. Возможное прямое влияние на активность мембран связано с изменениями в проводимости калия.; Улучшает психическое состояние и настроение больных, обладает антиаритмической активностью.; Высоко эффективен при абсансах и височных псевдоабсансах, мало - при психомоторных припадках."}}]},{"id":3,"name":"Показания к применению","slug":"indications","displayInMenu":true,"body":[{"type":"list","data":{"style":"unordered","items":["Эпилепсия различного генеза: генерализованные и парциальные припадки","Эпилептические припадки на фоне органических заболеваний мозга","Изменения характера и поведения (обусловленные эпилепсией)","Маниакально-депрессивный психоз с биполярным течением, не поддающийся лечению препаратами лития или другими лекарственными средствами","Специфические синдромы (Веста, Леннокса-Гасто)"]}}]},{"id":4,"name":"Противопоказания","slug":"contraindications","displayInMenu":true,"body":[{"type":"list","data":{"style":"unordered","items":["Печеночная недостаточность","Острый и хронический гепатит","Нарушения функции поджелудочной железы","Порфирия","Геморрагический диатез","Тромбоцитопения","Детский возраст до 3 лет","Заболевания печени в анамнезе","Повышенная чувствительность к препарату"]}}]},{"id":5,"name":"Применение при беременности и в период грудного вскармливания","slug":"pregnancy_warnings","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"При беременности применение Конвульсофина возможно только по строгим показаниям, после тщательной оценки ожидаемой пользы терапии для матери и возможного риска для плода.; При применении Конвульсофина в ранний период беременности повышается риск незаращения нервной трубки у эмбриона (миеломенингоцеле). Наряду с этим могут отмечаться другие аномалии развития плода. Риск образования аномалий развития плода увеличивается при комбинированном применении Конвульсофина с другими противоэпилептическими средствами.; В случае невозможности отказа от проведения терапии Конвульсофином в I триместре препарат назначают в самых низких дозах, а между 20 и 40 днем беременности суточную дозу распределяют на несколько небольших разовых доз в течение дня. Необходимо регулярно контролировать концентрацию вальпроевой кислоты в плазме крови. С целью ранней диагностики аномалий развития плода рекомендуется проводить УЗ-исследования и альфа1 -фетопротеиновый тест.; Вальпроевая кислота выделяется с материнским молоком в незначительных количествах, не представляющих опасности для ребенка, поэтому, как правило, прекращения грудного вскармливания в период терапии Конвульсофином не требуется."}}]},{"id":6,"name":"Способ применения и дозы","slug":"dosage","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"Внутрь, во время или после еды, не разжевывая и запивая небольшим количеством жидкости.; Во избежание побочных эффектов лечение начинают низкими дозами препарата, затем их постепенно повышают до оптимальных для больного суточных поддерживающих доз. При монотерапии начальная доза Конвульсофина в общем составляет 5–10 мг/кг. Через каждые 4–7 дней эту дозу увеличивают примерно на 5 мг. Средняя суточная доза для взрослых и больных пожилого и старческого возраста составляет 20 мг/кг, для подростков — 25 мг/кг и для детей — 30 мг/кг. В некоторых случаях терапевтическое действие препарата полностью проявляется только через 4–6 нед лечения. Поэтому необходимо следить за тем, чтобы увеличение суточной дозы произошло постепенно. Если Конвульсофин назначают вместе с другими противоэпилептическими средствами или для замещения предшествующего препарата, то дозу раннее принимаемого препарата, в особенности фенобарбитала, немедленно понижают. Полный переход на лечение Конвульсофином производят медленно, постепенно понижая дозу ранее принимаемого препарата.; Обычно руководствуются следующей ориентировочной схемой применения препарата: - детям в возрасте 3–6 лет назначают по 300–600 мг (1–2 табл.) в сутки; ;- детям школьного возраста (6–14 лет) назначают по 450–1500 мг (1,5–5 табл.) в сутки; ;- подросткам старше 14 лет и взрослым назначают по 1200–2100 мг (4–7 табл.) в сутки.; У больных с почечной недостаточностью следует учитывать повышение концентрации свободной вальпроевой кислоты в сыворотке крови и в соответствии с этим снижать суточную дозу Конвульсофина.; По указанию врача суточную дозу препарата распределяют на 2–4 приема в день.; Дозы и длительность применения Конвульсофина устанавливает врач индивидуально для каждого больного."}}]},{"id":7,"name":"Побочное действие","slug":"side_effects","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"Со стороны ЦНС: тремор; редко - изменения поведения, настроения или психического состояния (депрессия, чувство усталости, галлюцинации, агрессивность, гиперактивное состояние, психозы, необычное возбуждение, двигательное беспокойство или раздражительность), атаксия, головокружение, сонливость, головная боль, энцефалопатия, дизартрия, энурез, ступор, нарушение сознания, кома.; Со стороны органов чувств: диплопия, нистагм, мелькание \"мушек\" перед глазами, нарушение слуха.; Со стороны пищеварительной системы: тошнота, рвота, гастралгия, анорексия или повышение аппетита, диарея, гепатит, незначительное повышение активности печеночных трансаминаз, ЛДГ, гипербилирубинемия; редко - запоры, панкреатит (вплоть до тяжелых поражений с летальным исходом в первые 6 мес лечения, чаще на 2-12-й неделе).; Со стороны системы кроветворения: анемия, лейкопения.; Со стороны свертывающей системы крови: тромбоцитопения, снижение содержания фибриногена, удлинение времени кровотечения, петехиальные кровоизлияния, кровоподтеки, гематомы, повышенная кровоточивость.; Аллергические реакции: кожная сыпь, крапивница, ангионевротический отек, синдром Стивенса-Джонсона.; Дерматологические реакции: фотосенсибилизация, алопеция.; Со стороны мочевыделительной системы: гиперкреатининемия, гипераммониемия.; Со стороны эндокринной системы: дисменорея, вторичная аменорея, увеличение молочных желез, галакторея.; Прочие: увеличение или уменьшение массы тела, периферические отеки, гиперглицинемия."}}]},{"id":8,"name":"Передозировка","slug":"overdose","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"Симптомы: тошнота, рвота, головокружение, диарея, нарушение функции дыхания, мышечная гипотония, гипорефлексия, миоз, кома (на ЭЭГ увеличение медленных волн и фоновой активности).; Лечение: промывание желудка (не позже 10-12 ч), прием активированного угля, форсированный диурез, поддержание жизненно важных функций, гемодиализ."}}]},{"id":9,"name":"Особые указания","slug":"cautions","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"С особой осторожностью и под тщательным медицинским наблюдением следует назначать препарат при аплазии костного мозга, патологических изменениях крови, органических заболеваниях головного мозга, гипопротеинемии, почечной недостаточности.; Переход от лечения другим противосудорожным препаратом к терапии Конвульсофином производят медленно, достигая клинически эффективной дозы в течение 2 недель и постепенно понижая дозу предыдущего препарата вплоть до его отмены. У пациентов, не получавших предшествующего лечения противоэпилептическими препаратами, клинически эффективная доза должна быть достигнута через 1 неделю.; Побочное действие чаще возникает при проведении комбинированной терапии, чем при монотерапии Конвульсофином.; Перед хирургическими манипуляциями больным, принимающим Конвульсофин, следует определять количество тромбоцитов, время кровотечения, показатели коагулограммы.; При развитии на фоне приема Конвульсофина симптомокомплекса \"острый живот\" до начала оперативного вмешательства рекомендуется определить уровень амилазы в крови для исключения острого панкреатита.; При развитии спонтанных гематом и кровотечений и возникновении таких симптомов, как слабость, летаргическое состояние, отечность, рвота и желтуха, следует немедленно прекратить применение препарата.; Следует учитывать, что на фоне приема Конвульсофина возможны ложноположительные реакции на наличие кетоновых тел в моче, искажение показателей функции щитовидной железы.; В период лечения Конвульсофином не допускается прием этанолсодержащих напитков.; Контроль лабораторных показателей; На фоне терапии Конвульсофином необходимо периодически контролировать активность печеночных трансаминаз, уровень билирубина, картину периферической крови, уровень фибриногена в плазме крови, тромбопластиновое время, уровень альфа-амилазы в моче (каждые 3 месяца).; Использование в педиатрии; У детей (особенно до 2 лет) повышен риск развития выраженных нарушений функции печени на фоне приема Конвульсофина.; Влияние на способность к вождению автотранспорта и управлению механизмами; Препарат может ослаблять скорость психомоторных реакций и способность к концентрации внимания, поэтому пациентам, принимающим Конвульсофин, следует воздерживаться от потенциально опасных видов деятельности."}}]}],"source":{"title":"36.6","url":"https://366.ru"}},"description_toggle":false,"short_description":"Противоэпилептический препарат. 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